About the Zenith Flex® AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System
What is the Zenith Flex AAA Endovascular Graft?
The Zenith Flex AAA Endovascular Graft is made up of three parts: a main body and two “legs.” The main body is positioned in the aorta. The legs are positioned in the iliac arteries and connect to the main body. The graft thus extends from the aorta below the renal arteries leading to the kidneys into both iliac arteries.
The graft itself is made of a polyester graft material like that used in open surgical repair. Standard surgical suture is used to sew the graft material to a frame of stainless steel stents. These self-expanding stents provide support. The graft has several gold markers to help your doctor see the device during placement. All of these materials have a long history of use in medical implants.
Thousands of patients worldwide have received a Zenith AAA Endovascular Graft.
What results have been seen with the Zenith AAA Endovascular Graft?
A clinical study of 280 patients in the U.S. compared patients treated with the Zenith AAA Endovascular Graft with the H&L-B One-Shot Introduction System with patients treated with open surgical repair.* Patients treated with the Zenith AAA Endovascular Graft with the H&L-B One-Shot Introduction System had fewer major problems during treatment and recovery. They lost less blood and were less likely to need a blood transfusion while in the hospital. They spent fewer days in intensive care. They were able to drink and eat sooner, and their bowel function returned to normal sooner. They were able to walk sooner, and were discharged from the hospital sooner. Patients answered questions about how they felt. Patients treated with the Zenith AAA Endovascular Graft with the H&L-B One-Shot Introduction System had more energy, less pain and felt better.
*Data on file.
How is the graft implanted?
Before the procedure, your doctor looks at pictures of your aorta (CT scan and angiography). From these pictures, the doctor can choose the proper size for each part of the Zenith Flex AAA Endovascular Graft so that it will fit your blood vessels. During the procedure, the doctor uses X-rays to see the graft and position it correctly.
Before the graft is implanted, each of its three parts is contained in its own sheath (plastic tube) called the H&L-B One-Shot™ Introduction System. The plastic tubes are removed after the graft is put in place.
To place the graft, your doctor makes a small cut near each hip (near the crease between the abdomen and thigh) to get to the femoral arteries (blood vessels). Through these small cuts, each part of the graft is inserted separately into your bloodstream. The main body is positioned in the aorta. The legs extend from the main body into the iliac arteries. When each part of the graft is released from its tube, it opens up to fill and reinforce the blood vessels (aorta, iliac arteries). When both legs are connected to the main body, the graft seals off (excludes) the aneurysm.
Before the procedure is finished, your doctor uses X-rays to confirm that the blood in the aorta flows through the graft, not through the aneurysm. Your doctor will then close up the cut in each leg with a few stitches.